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About Sterile Open Vials

SCHOTT Fiolax Type I Glass Vials are processed and depyrogenated by Disposable Lab under cGMP conditions to produce Pyrofree® Sterile Open Vials, which are supplied with full Sterility and Endotoxin Certification.

Pyrofree® is the only packaging process that enables the vials to be depyrogenated in their final packaging which eliminates any risk of endotoxin contamination during the oven exit or further handling.

In addition, as vials are packed under vacuum, the visible integrity of this vacuum guarantees the sterility of the vials and also provides tamper evidence.

Pyrofree® Vials — Pack and Batch Quantities

Vial

Pack Size

Packs per Batch

Batch Size

2R

248

59

14,632

4R

248

59

14,632

6R

132

59

7,788

8R

132

59

7,788

10R

109

59

6,431

15R

109

59

6,431

20R

63

59

3,717

30R

63

28

1764

50ml

31

28

868

Additional Product Information

More about Sterile Open Vials

Your choice of Type I Glass Injection Vial is first washed with WFI (Water For Injection) then packed under vacuum into two layers of PEEK polymer, a novel polymer able to withstand the high temperatures of a depyrogenation oven.

The glass vials in the PEEK pouches are then sterilised by dry heat in a depyrogenation oven according to a validated process.

They are then vacuum packed in a third PE/EvOH/PA pouch to offer external protection.

The major benefit of using the conventional dry heat sterilisation method to process these Sterile Open Vials is that, unlike sterilisation through EtO, any trial work conducted using these vials is easily replicated on scaled up production equipment.

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We would love to keep you updated with our products and innovations, as well as news about Adelphi. If you are happy for us to do so, please tick the box to opt in. You can revoke this consent at any time.